UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-000401
`Patent 7,326,708
`__________________
`
`
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO FILE
`REQUEST FOR CERTIFICATE OF CORRECTION OF CLAIMS 5–7
`
`
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as
`parties to this proceeding via Motion for Joinder in IPR2020-01045; Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as parties to this
`proceeding via a Motion for Joinder in IPR2020-01060; and Sun Pharmaceuticals
`Industries Ltd. was joined as a party to this proceeding via Motion for Joinder in
`IPR2020-01072.
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-000401
`Patent 7,326,708
`__________________
`
`
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO FILE
`REQUEST FOR CERTIFICATE OF CORRECTION OF CLAIMS 5–7
`
`
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as
`parties to this proceeding via Motion for Joinder in IPR2020-01045; Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as parties to this
`proceeding via a Motion for Joinder in IPR2020-01060; and Sun Pharmaceuticals
`Industries Ltd. was joined as a party to this proceeding via Motion for Joinder in
`IPR2020-01072.
`
`
`
`Case IPR2020-00040 | Patent 7,326,708
`
`
`
`TABLE OF AUTHORITIES
`
`ArthroCare Corp. v. Smith & Nephew, Inc.,
`406 F.3d 1365 (Fed. Cir. 2005) .............................................................. 1, 2
`
`Cent. Admixture Pharm. Servs. Inc. v. Adv. Cardiac Sols. P.C.,
`482 F.3d 1347 (Fed. Cir. 2007) .................................................................. 1
`
`Honeywell Int’l, Inc. v. Arkema Inc.,
`939 F.3d 1345 (Fed. Cir. 2019) .................................................................. 1
`
`Inventio AG v. ThyssenKrupp Elevator Americas Corp.,
`718 F. Supp. 2d 529 (D. Del. 2010) ............................................................ 2
`
`ipDataTel, LLC v. ICN Acquisition, LLC,
`2019 WL 1771940 (P.T.A.B. Apr. 22, 2019)................................................ 2
`
`Novo Indus., LP v. Micro Molds Corp.,
`350 F.3d 1348 (Fed. Cir. 2003) .............................................................. 2, 3
`
`ParkerVision, Inc. v. Qualcomm Inc.,
`969 F. Supp. 2d 1372 (M.D. Fla. 2013) ....................................................... 2
`
`35 U.S.C. § 255 ..................................................................................... 1, 2, 3
`
`MPEP § 1481 ............................................................................................... 2
`
`
`
`i
`
`
`
`Case IPR2020-00040 | Patent 7,326,708
`
`
`
`Petitioners’ Opposition never disputes the standard for when an error is
`
`sufficiently “ministerial” that it can be corrected via a certificate: whether it is
`
`“clearly evident from the specifications, drawings, and prosecution history how the
`
`error should appropriately be corrected.” ArthroCare Corp. v. Smith & Nephew,
`
`Inc., 406 F.3d 1365, 1374–75 (Fed. Cir. 2005). Nor do Petitioners dispute Merck’s
`
`evidence that the person of ordinary skill in the art (“POSA”) would recognize that
`
`the “absorption band” claim language should instead have referred to “diffraction
`
`peaks,” as in the specification. Mot. 6; EX2278 ¶¶ 69–71; EX2280 ¶¶ 14–17.
`
`Petitioners are wrong that Merck is relying on the inventors’ subjective mindset;
`
`the error is plain from the specification, so it is irrelevant that Merck does not look,
`
`or need to look, to the prosecution history. Opp. 6–7. These facts establish
`
`Merck’s entitlement to a certificate on the merits—never mind under the lower
`
`threshold that undisputedly applies to whether the Board should grant Merck leave.
`
`Honeywell Int’l, Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019).
`
`Contrary to the Opposition, nothing further is needed for Merck to show that
`
`the error is “clerical or typographical” or “of minor character.” 35 U.S.C. § 255.
`
`The existence of an error and an appropriate correction that are “clearly evident to
`
`one of skill in the art” establish that element. Cent. Admixture Pharm. Servs. Inc.
`
`v. Adv. Cardiac Sols. P.C., 482 F.3d 1347, 1353 (Fed. Cir. 2007). But even if
`
`some further showing were needed, Merck readily meets it. Certificates frequently
`
`1
`
`
`
`Case IPR2020-00040 | Patent 7,326,708
`
`
`
`are granted to change wording errors that go beyond “obvious misspellings” (Opp.
`
`2). ArthroCare, 406 F.3d at 1374 (changing “active electrode” to “electrode
`
`terminal”); ipDataTel, LLC v. ICN Acquisition, LLC, 2019 WL 1771940, at *5–6
`
`(P.T.A.B. Apr. 22, 2019) (changing “synchronization to associate” to “association
`
`to synchronize”). Joinder Petitioners’ own expert characterized the amendments
`
`here as “a mistake or typographical error.” EX2277 at 92:20–23; EX2279 ¶ 46.
`
`Petitioners’ argument that certificates of correction cannot correct indefinite
`
`claim language is simply wrong. The Federal Circuit has recognized that
`
`certificates under § 255 can do just that. Novo Indus., LP v. Micro Molds Corp.,
`
`350 F.3d 1348, 1356 (Fed. Cir. 2003). Petitioners dismiss this as “dicta,” Opp. 3,
`
`but the PTO repeatedly has issued certificates that fix indefinite claim language.
`
`E.g., ipDataTel, 2019 WL 1771940, at *5–6; Inventio AG v. ThyssenKrupp
`
`Elevator Americas Corp., 718 F. Supp. 2d 529, 569–70 (D. Del. 2010); see also
`
`ParkerVision, Inc. v. Qualcomm Inc., 969 F. Supp. 2d 1372, 1379 (M.D. Fla. 2013)
`
`(recognizing PTO’s authority to correct claims that are otherwise indefinite). That
`
`there is no MPEP provision permitting correction of terminal disclaimers, Opp. 4,
`
`is irrelevant; here, 35 U.S.C. § 255 and MPEP § 1481 allow correcting mistakes
`
`like the one here without regard to whether the mistakes rendered claims indefinite.
`
`And the suggestion that certificates can only correct “minor” errors that do not
`
`affect validity, Opp. 4–5, is backwards; mistakes that are too “trivial” or
`
`2
`
`
`
`
`
`“inconsequential” “will not warrant” correction. Novo, 350 F.3d at 1356.
`
`Case IPR2020-00040 | Patent 7,326,708
`
`There is no basis for Petitioners’ argument that the correction constitutes
`
`new matter or that reexamination is needed here. The corrected language is
`
`directly from the specification. There is no indication that claims reciting the
`
`correct language would have been examined any differently. Merck even
`
`successfully overcame a double patenting rejection by using diffractograms—i.e.,
`
`XRPD patterns—to distinguish different crystal forms based on their characteristic
`
`diffraction peaks, showing that the examiner understood their relevance. EX1010
`
`at 153–56, 241–42, 245–48. Petitioners, moreover, simply ignore the authority
`
`that whether reexamination is required is not a question for the Board. Mot. 8.
`
`Finally, Petitioners’ assertions that “good faith” is somehow undermined by
`
`the fact that the mistake was inadvertent make no sense. Opp. 7–9. There is no
`
`suggestion that the choice of language or the timing is based on gamesmanship,
`
`and Merck comes to the Board promptly after the district court held the claims
`
`indefinite. Petitioners’ cases condemning parties’ inattention in reviewing claims
`
`are not about the “good faith” prong of 35 U.S.C. § 255 and do not bar correction
`
`of inadvertent mistakes that otherwise meet § 255’s standards. And again, “good
`
`faith” is not for the Board to decide. Mot. 7.
`
`Merck has no objection to the submission of the briefing with its request to
`
`the Director, so long as all the briefing—not just the Opposition—is included.
`
`3
`
`
`
`
`
`Date: December 11, 2020
`
`
`
`
`
`
`Case IPR2020-00040 | Patent 7,326,708
`
`
`
`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`David M. Krinsky (Reg. No. 72,339)
`Elise M. Baumgarten (Pro Hac Vice)
`Alexander S. Zolan (Pro Hac Vice)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`dkrinsky@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`
`
`4
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`
`
`
`
`Case IPR2020-00040 | Patent 7,326,708
`
`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
`
`and correct copy of the foregoing was served on December 11, 2020, by delivering
`
`a copy via electronic mail on the following attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`550 South Tryon, Street Suite 2900
`Charlotte, NC 28202-4213
`(704) 444-2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`Russell W. Faegenburg
`Tedd W. Van Buskirk
`Michael H. Teschner
`LERNER, DAVID, LITTENBERG,
`KRUMHOLZ & MENTLIK, LLP
`20 Commerce Drive
`Cranford, New Jersey 07016
`(908) 518-6367
`Rfaegenburg.ipr@ldlkm.com
`Tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`MTeschner.ipr@ldlkm.com
`
`
`
`
`
`
`Keith A. Zullow
`Sarah J. Fischer
`Emily L. Rapalino
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eight Avenue
`New York, NY 10018
`kzullow@goodwinprocter.com
`sfischer@goodwinprocter.com
`erapalino@goodwinprocter.com
`
`Jovial Wong
`Charles B. Klein
`Claire A. Fundakowski
`Zachary B. Cohen
`WINSTON & STRAWN LLP
`1901 L. Street, N.W.
`Washington, D.C. 20036
`(202) 282-5000
`Sunipr@winston.com
`
`
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`5
`
`
`
`
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